Heart failure affects approximately three million Americans, and new cases of heart failure number about 400,000 each year. Congestive heart failure (CHF) is particularly insidious, affecting at least two million Americans, and is a syndrome characterized by left ventricular dysfunction, reduced exercise tolerance, impaired quality of life, and markedly shortened life expectancy. In patients suffering from CHF, decreased contractility of the left ventricle leads to reduced cardiac output with consequent systemic arterial and venous vasoconstriction. This vasoconstriction, which promotes the vicious cycle of further reductions of stroke volume is followed by an increased elevation of vascular resistance. A number of techniques are available for treating cardiovascular disease such as cardiovascular by-pass surgery, coronary angioplasty, laser angioplasty and atherectomy. These techniques are generally applied to by-pass or open lesions in coronary vessels to restore and increase blood flow to the heart muscle. In some patients, the number of lesions are so great, or the location so remote in the patient vasculature that restoring blood flow to the heart muscle is difficult.
However, despite these efforts, the degree of clinical efficacy has been limited. Improvement in functional capacity and exercise time is small and-mortality, although reduced, continues to be high. Thus, there remains a long felt, yet currently unmet need to provide a therapeutic solution to minimize the deterioration of the heart associated with CHF.
The prior art method of delivering therapeutics using needle injection is problematic because such treatment is too localized. Also there are problems associated with patch delivery whereby a biologically active material is incorporated into a patch. Patch delivery provides a means of localizing and controlling therapeutic agent release to the heart and other organs. Currently, affixing such delivery vehicles to the myocardium is only achieved with maximally invasive surgical techniques (i.e. open-heart surgery). Hence, direct exposure of the heart is necessary for patch attachment. Clearly, there remains a great need for a medical device which delivers therapeutic agents that is minimally invasive. With the device as described in the present invention, patch delivery can be accomplished using a minimally invasive catheter-based delivery system.